- Grifols Shared Services North America, Inc (Clayton, NC)
- …and regions. **Overview:** The Engineer I - Validation / Engineer II - Validation / Validation Specialist I / Validation Specialist II / Sr. ... 2-4 years experience which can include Co-Op or internship **Sr. Specialist I** - Validation - Requires a BS/BA degree in STEM (Science, Technology, Engineering,… more
- Stantec (Raleigh, NC)
- Senior Commissioning/ Validation Specialist - ( 250001UF ) **Description** Stantec Buildings is on a mission to become the world's leading integrated design ... group for an enthusiastic, diligent and experienced Commissioning / Validation Specialist . In this role you will prepare and implements project commissioning/… more
- Actalent (Clayton, NC)
- Validation Specialist Job Description As a Validation Specialist , you will perform revalidation on equipment and processes according to approved ... timelines. You will support validation activities related to changes in existing and new...+ Manage Change Requests related to revalidation and other validation activities. + Author and review validation … more
- Novo Nordisk (Durham, NC)
- …what matters. The Position Coordinate & drive implementation of science & risk-based validation . The incumbent will provide input to project team members through all ... & commissioning/qualification/verification. Subject matter expert for all NN corporate validation procedures. Perform revalidation on equipment/processes per approved timelines.… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The QA Specialist , QC Compliance is responsible for partnering in the Quality oversight of the Quality Control area. The QA Specialist ... from project phase through operational readiness, and provides oversight of validation program execution for these processes. This role collaborates with other… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The QA Specialist , Drug Substance Manufacturing (DSM) is responsible for partnering in the Quality oversight of DSM project processes. This ... role provides oversight of validation program execution for these processes and systems to...with a focus on consistent policy administration. The QA Specialist , Drug Substance Manufacturing (DSM) ensures QA oversight of… more
- Novo Nordisk (Durham, NC)
- …department. Position will also be responsible for the production activities & validation . Ensuring relevant compliance issues are addressed & handled in close ... + Authority for product release + Quality oversight, review & approval of validation activities associated with projects, new systems, changes to existing systems &… more
- Novo Nordisk (Clayton, NC)
- …make what matters. The Position Responsible for the production activities & validation . Ensures relevant compliance issues are addressed & handled in close ... current NN procedures & requirements from health authorities are reflected in the validation planning & quality related decisions + Support validation projects… more
- Norstella (Raleigh, NC)
- Data Enhancement Specialist Company: MMIT Location: Remote, United States Date Posted: Apr 22, 2025 Employment Type: Full Time Job ID: R-1137 **Description** **_Why ... the entire drug development journey. **The Role:** As a Specialist on the Enterprise Access & Data Expertise Team...understanding of knowledge, data, and product to resolve data validation requests in accordance with MMIT standards and client… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The QA Specialist , Operations (Nights) is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes for ... * 1-3 years' experience in a GMP environment * Experience in Validation , cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility… more
- Nutanix (Durham, NC)
- **Hungry, Humble, Honest, with Heart.** **The Opportunity** The Presales Readiness Specialist is a strategic individual contributor responsible for designing and ... role ensures SEs are equipped with core competencies in technical validation , demo execution, solution positioning, and customer engagement-enabling them to lead… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …needs in a very timely and accurate manner. **_Sr Reg Affairs Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative ... or a Master's degree with 2 years of experience._ **_Sr. Reg Affairs Specialist II_** **Primary responsibilities for role:** + Act as Regulatory Affairs authority… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Sr. Specialist 2, QC Instrumentation manages routine operations, continuous improvement, and life-cycle management of the QC analytical ... in alignment with regulatory guidelines and company policies. The Sr. Specialist executes and monitors the performance of routine maintenance, performs periodic… more
- Novo Nordisk (Clayton, NC)
- …+ Oversee area content and provide process knowledge, periodic reviews, validation processes, and reporting + Demonstrate technical knowledge of assigned processes ... assigned processes, including assessment of deviations, root cause analysis, validation and process changes/improvements + Evaluate process/maintenance data to… more
- Amgen (Holly Springs, NC)
- …equipment/system design, specification and supporting the construction, startup, and validation of equipment. + Develop equipment maintenance programs, ensure the ... as change control, non-conformances, corrective and preventative actions, and qualifications/ validation + Experience applying engineering principles to the design… more
- Truist (Raleigh, NC)
- …locations based on need for geographical resiliency. The Operational Resilience Senior Specialist - DR Planning & Testing position is responsible to support the ... and testing with business units and technology teams for plan validation and compliance documentation. 3. Manages and facilitates enterprise response… more
- Fujifilm (Raleigh, NC)
- **Position Overview** The accomplished Senior Corporate Compliance Specialist will support FUJIFILM's Corporate Compliance Program's operations to ensure high ... plans, and prepare related reports. + Manage transparency data collection, validation , and reporting process to ensure compliance with the applicable transparency… more
- Merck (Durham, NC)
- …product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion. Project activities requiring support include ... cross-functional team with executing and approving change controls. + Approve cleaning validation documentation as needed. + May act as a Quality Risk Assessment… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Sr. Specialist 2, Global QC Raw Materials GMP Support is responsible for supporting, leading, and participating in activities within the ... Global QC RM area * Provides risk assessments, regulatory standards/guidance, and validation documents, as required to support QC business and compliance *… more
- Cardinal Health (Raleigh, NC)
- …of quality, analytical metrics and / or statistics, trending, quality planning, validation , CAPA and problem solving. + Works cross-functionally and has the ability ... to interpret the requirements as well as educate and influence others on those requirements. **_Qualifications_** + Bachelors in related field, or equivalent work experience, preferred + 4+ years experience in related field, preferred + PET Quality Experience,… more